Study to Evaluate Safety, Tolerability and Pharmacokinetics of G01 Eye Drops in Healthy Volunteers

Summary

The primary objective of this study is to assess the safety and tolerability of single and multiple ascending doses of G01 when administered as eye drops in healthy subjects.

Conditions

• Healhty

Interventions

DRUG

G01 Eye Drops 100 µg/mL SAD

all subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level

DRUG

G01 Eye Drops 200 µg/mL SAD

All subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level

DRUG

G01 Eye Drops 400 µg/mL SAD

All subjects received two 33-μL drops of G01 Eye Drops at an appropriate concentration in the study eye according to the randomisation list to achieve the required dose level

DRUG

G01 Eye Drops 100 µg/mL MAD

All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.

DRUG

G01 Eye Drops 200 µg/mL MAD

All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.

DRUG

G01 Eye Drops 400 µg/mL MAD

All subjects receive two 33-μL drops of G01 Eye Drops at the predefined concentration in the study eye according to the randomisation list to achieve the required dose level, which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.

DRUG

Placebo of G01 Eye Drops SAD

All subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list

DRUG

Placebo of G01 Eye Drops MAD

All subjects receive two 33-μL drops of G01 Eye Drops Placebo in the study eye according to the randomisation list , which is administered three times daily (morning, midday, and bedtime) for six consecutive days from Day 1 to Day 6, with only one single morning instillation on Day 7.

Sponsors & Collaborators

• Qingdao WanMing BioCell Pharmaceutics Co.,Ltd.

  lead INDUSTRY

Principal Investigators

• Yuzhong Wang · Affiliated Hospital of Jining Medical University

Study Design

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

QUADRUPLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

50 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2024-12-12

Primary Completion

2025-06-28

Completion

2025-06-28

Countries

• China

Study Locations